Study Protocol: A Randomized Controlled Trial of a Mindfulness Intervention to Reduce Low Back Pain, Psychological Symptoms and Enhance Work Productivity Among Academic Staff in Malaysian Tertiary Education
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 主要终点
- Low back pain intensity
研究概览
简要总结
Mindfulness interventions are a well-known approach for improving mental health. Nevertheless, the available evidence regarding their efficacy in addressing musculoskeletal pain (MSP) is limited, despite numerous studies demonstrating an association between psychological factors and MSP. Both mental health issues and MSP are prevalent among academicians, yet there is a scarce study on the application of mindfulness interventions to these specific concerns. Therefore, this study aimed to provide a study protocol that will focus on assessing the impact of mindfulness interventions on alleviating low back pain (LBP) symptoms, psychological symptoms, and improving work productivity among academic staff.
详细描述
This study acknowledges the significance of mindfulness interventions, primarily introduced by Jon Kabat-Zinn. Mindfulness, rooted in various religious traditions, has been associated with improved well-being. The efficacy of mindfulness interventions in addressing anxiety and mood disorders is supported by meta-analyses, indicating moderate effectiveness. The focus then shifts to workplace interventions, noting a rising trend in research on mindfulness from 2012 to 2022. Studies highlight its efficacy not only in mental health aspects among employees but also in reducing musculoskeletal disorders.
Previous studies revealing the positive impact of mindfulness on chronic musculoskeletal pain, psychological well-being, and overall health-related quality of life among nurses. Another study in Denmark combines mindfulness with physical and cognitive elements, demonstrating reductions in pain intensity across various body regions. While mindfulness in the workplace is well-explored, its application in academia, particularly among university teachers, is relatively new. Previous scoping review explores various psychological interventions, including Mindfulness-Based Interventions, cognitive behavioural therapy (CBT), and yoga, to reduce stress and burnout among teachers, but cautions against generalizing these findings to academicians due to the heterogeneity of their work nature.
Based on the fact mentioned above, it is imperative to initiate mindfulness interventions among the academicians targeting to reduce low back pain, psychological symptoms and enhance work productivity. As of our latest information, there are no existing programs accessible for this specific implementation in Malaysia. The specific objectives for this trial were as follows
- To identify the efficacy of the mindfulness intervention in reducing the pain intensity of LBP among academic staffs.
- To identify the efficacy of the mindfulness intervention in reducing depression and anxiety symptoms among academic staffs.
- To identify the efficacy of the mindfulness intervention in improving work productivity among academic staffs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Eligible participants were invited to participate in the interventional study. Their participation must be voluntarily. Those who agreed to participate will be randomized either to the intervention and wait-list control group. The participants will remain unaware of their group assignment, as the randomization sequence will be generated using computer-based randomization. This is known as single-blind study. Allocation will follow a 1:1 ratio, overseen by a researcher with no other involvement in this trial. The participants' names will be matched with the random number sequence. Clusters of participants were in the same workplace to avoid contamination of the intervention and enhance compliance within the intervention group
入排标准
- 年龄范围
- 28 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Pregnancy or had planned to become pregnant in the coming months,
- •History of trauma or accidents in the spinal region
- •Medically diagnosed with congenital anomaly of the spine, rheumatoid arthritis, infections of the spine or discs, ankylosing spondylitis, spondylolisthesis, spondylosis, spinal tumor, systemic lupus erythymatosus, or osteoporosis.
- •Had performed either spinal, intra-abdominal or femoral surgery.
结局指标
主要结局
Low back pain intensity
时间窗: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Visual Analogue Scale (VAS) will be used to measure the participants' pain intensity during the pre and post-test. A VAS is commonly presented with unidimensional line, usually 100-mm long, starts from 0 'no pain' to 100 'severe intolerable pain'. Participants who reported pain at each anatomical site will be further asked to indicate which point along the line best represents their pain intensity.
Low back pain occurrence
时间窗: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
The questions about musculoskeletal pain focused on seven anatomical sites will be adapted based on the Nordic Musculoskeletal Questionnaire. The seven anatomical sites include low back, neck, right or/and left shoulder, right or/and left elbow, right or/and left wrist/hand and right or left knee, and right or left ankle with the binary response (yes/no). The instrument has an acceptable psychometric property and widely applied in Malaysian working population. During the screening process, participants will be asked whether they had experienced on low back pain during the past months that had lasted for longer than a day which were illustrated diagrammatically. After the intervention, the occurrence of low back pain pain will be re-assessed by asking whether they had experienced pain for each anatomical site, during the past months that had lasted for longer than a day which were illustrated diagrammatically.
次要结局
- Psychological symptoms (anxiety)(Pre (week 0), Post intervention (week 5) and Follow-up (week 18))
- Absenteeism and Presenteeism(Pre (week 0), Post intervention (week 5) and Follow-up (week 18))
- Psychological symptoms (depression)(Pre (week 0), Post intervention (week 5) and Follow-up (week 18))
研究者
Eva Zamri
Principal Investigator
Universiti Sains Malaysia